01 1ALP Pharm
02 1Bayer AG
03 1Daewoong Pharmaceutical
04 1Sichuan Renan Pharmaceutical
01 4IOPROMIDE
01 2China
02 1Germany
03 1South Korea
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35356
Submission : 2020-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8178
Submission : 1989-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25680
Submission : 2012-01-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38239
Submission : 2023-04-09
Status : Active
Type : II
A Iopromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iopromide, including repackagers and relabelers. The FDA regulates Iopromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iopromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Iopromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iopromide supplier is an individual or a company that provides Iopromide active pharmaceutical ingredient (API) or Iopromide finished formulations upon request. The Iopromide suppliers may include Iopromide API manufacturers, exporters, distributors and traders.
click here to find a list of Iopromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iopromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Iopromide active pharmaceutical ingredient (API) in detail. Different forms of Iopromide DMFs exist exist since differing nations have different regulations, such as Iopromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iopromide DMF submitted to regulatory agencies in the US is known as a USDMF. Iopromide USDMF includes data on Iopromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iopromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iopromide suppliers with USDMF on PharmaCompass.
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